External steerable fiber for use in endoluminal deployment of expandable devices

ABSTRACT

The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise a steering line or lines which facilitate bending and steering of the expandable implant through the vasculature of a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/610,372, entitled “EXTERNAL STEERABLE FIBER FOR USE INENDOLUMINAL DEPLOYMENT OF EXPANDABLE DEVICES” and filed Mar. 13, 2012,which is hereby incorporated by reference in its entirety.

BACKGROUND

1. Field

The present disclosure relates generally to endoluminal devices and,more specifically, to expandable endoluminal devices steerable withinthe vasculature of a patient.

2. Discussion of the Related Art

Endoluminal therapies typically involve the insertion of a deliverycatheter to transport an implantable prosthetic device into thevasculature through a small, often percutaneous, access site in a remotevessel. Once access to the vasculature is achieved, the deliverycatheter is used to mediate endoluminal delivery and subsequentdeployment of the device via one of several techniques. In this fashion,the device can be remotely implanted to achieve a therapeutic outcome.In contrast to conventional surgical therapies, endoluminal treatmentsare distinguished by their “minimally invasive” nature.

Expandable endoluminal devices can be comprised of a graft or a stentcomponent with or without a graft covering over the stent interstices.They can be designed to expand when a restraint is removed or to beballoon-expanded from their delivery diameter, through a range ofintermediary diameters, up to a maximal, pre-determined functionaldiameter.

It remains desirable to provide improved systems for endoluminaldelivery and deployment of expandable endoluminal devices to vasculartreatment sites.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure andtogether with the description serve to explain the principles of thedisclosure, wherein:

FIG. 1 illustrates a side view of a catheter assembly having anexpandable implant;

FIGS. 2A and 2B illustrate perspective views of catheter assemblieshaving expandable implants;

FIGS. 3A-3B and 3C-3D illustrate cross-sectional and perspective views,respectively, of catheter assemblies having expandable implants;

FIG. 4A-4D illustrates various profile views of a distal end of anexpandable implant;

FIGS. 5A-5D illustrate perspective views of a catheter assembly havingan expandable implant;

FIG. 6 illustrates a perspective view of an expandable implant;

FIGS. 7A-7H illustrate cross-sectional views of an expandable implantand sleeve;

FIG. 8 illustrates a cross-sectional view of catheter assembly having anexpandable implant;

FIG. 9 illustrates a side view of a catheter assembly having anexpandable implant;

FIG. 10A illustrates a side view of a catheter assembly having anexpandable implant;

FIGS. 10B-10D illustrate inner curve, outer curve, and open viewsrespectively of the expandable implant and steering lines illustrated inFIG. 10A; and

FIGS. 11A-11B illustrate additional embodiments of expandable implantshaving steering lines.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatuses configured to perform the intended functions. Stateddifferently, other methods and apparatuses can be incorporated herein toperform the intended functions. It should also be noted that theaccompanying drawing figures referred to herein are not all drawn toscale, but can be exaggerated to illustrate various aspects of thepresent disclosure, and in that regard, the drawing figures should notbe construed as limiting. Finally, although the present disclosure canbe described in connection with various principles and beliefs, thepresent disclosure should not be bound by theory.

Throughout this specification and in the claims, the term “distal”refers to a location that is, or a portion of an endoluminal device(such as a stent-graft) that when implanted is, further downstream withrespect to blood flow than another portion of the device. Similarly, theterm “distally” refers to the direction of blood flow or furtherdownstream in the direction of blood flow.

The term “proximal” refers to a location that is, or a portion of anendoluminal device that when implanted is, further upstream with respectto blood flow than another portion of the device. Similarly, the term“proximally” refers to the direction opposite to the direction of bloodflow or upstream from the direction of blood flow.

With further regard to the terms proximal and distal, and because thepresent disclosure is not limited to peripheral and/or centralapproaches, this disclosure should not be narrowly construed withrespect to these terms. Rather, the devices and methods described hereincan be altered and/or adjusted relative to the anatomy of a patient.

Throughout this specification and in the claims, the term “leading”refers to a relative location on a device which is closer to the end ofthe device that is inserted into and progressed through the vasculatureof a patient. The term “trailing” refers to a relative location on adevice which is closer to the end of the device that is located outsideof the vasculature of a patient.

In various embodiments, a catheter assembly is disclosed which utilizesone or more flexible sleeves that (i) releasably constrain an expandableimplant, such as an expandable endoluminal stent graft, toward adimension suitable for endoluminal delivery of the implant to atreatment site, such as a vascular member in a patient's body; and (ii)further constrain the implant to an outer peripheral dimension that islarger than the dimension suitable for endoluminal delivery but smallerthan an unconstrained or fully deployed outer peripheral dimension,thereby facilitating selective axial and/or rotational positioning orother manipulation of the implant at the treatment site prior to fulldeployment and expansion of the implant.

Various embodiments of the present disclosure comprise a catheterassembly configured to deliver an expandable implant to a treatment areaof the vasculature of a patient. In accordance with a number ofembodiments, the catheter assembly includes at least one steering linethat allows for selective bending of the expandable implant within thevasculature.

With initial reference to FIG. 1, a catheter assembly 100 in accordancewith the present disclosure comprises an expandable implant 106.Expandable implant 106 can comprise any endoluminal device suitable fordelivery to the treatment area of a vasculature. Such devices mayinclude, for example, stents, grafts, and stent grafts. Thus, expandableimplant can include one or more stent components with one or more graftmembers disposed over and/or under the stent, which can dilate from adelivery diameter, through a range of larger intermediary diameters, andtoward a maximal, pre-determined functional diameter

In various embodiments, expandable implant 106 comprises one or morestent components made of nitinol and a graft member made of ePTFE.However, and as discussed below, any suitable combination of stentcomponent(s) and graft member(s) is within the scope of the presentdisclosure.

For example, stent components can have various configurations such as,for example, rings, cut tubes, wound wires (or ribbons) or flatpatterned sheets rolled into a tubular form. Stent components can beformed from metallic, polymeric or natural materials and can compriseconventional medical grade materials such as nylon, polyacrylamide,polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate,polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene,polyvinylchloride, polyurethane, elastomeric organosilicon polymers;metals such as stainless steels, cobalt-chromium alloys and nitinol andbiologically derived materials such as bovine arteries/veins,pericardium and collagen. Stent components can also comprisebioresorbable materials such as poly(amino acids), poly(anhydrides),poly(caprolactones), poly(lactic/glycolic acid) polymers,poly(hydroxybutyrates) and poly(orthoesters). Any expandable stentcomponent configuration which can be delivered by a catheter is inaccordance with the present disclosure.

Moreover, potential materials for graft members include, for example,expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane,fluoropolymers, such as perfouorelastomers and the like,polytetrafluoroethylene, silicones, urethanes, ultra high molecularweight polyethylene, aramid fibers, and combinations thereof. Otherembodiments for a graft member material can include high strengthpolymer fibers such as ultra high molecular weight polyethylene fibers(e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g.,Technora®, etc.). The graft member may include a bioactive agent. In oneembodiment, an ePTFE graft includes a carbon component along a bloodcontacting surface thereof. Any graft member which can be delivered by acatheter is in accordance with the present disclosure.

In various embodiments, a stent component and/or graft member cancomprise a therapeutic coating. In these embodiments, the interiorand/or exterior of the stent component and/or graft member can be coatedwith, for example, a CD34 antigen. Additionally, any number of drugs ortherapeutic agents can be used to coat the graft member, including, forexample heparin, sirolimus, paclitaxel, everolimus, ABT-578,mycophenolic acid, tacrolimus, estradiol, oxygen free radical scavenger,biolimus A9, anti-CD34 antibodies, PDGF receptor blockers, MMP-1receptor blockers, VEGF, G-CSF, HMG-CoA reductase inhibitors,stimulators of iNOS and eNOS, ACE inhibitors, ARBs, doxycycline, andthalidomide, among others.

In various embodiments, expandable implant 106 can comprise a radiallycollapsed configuration suitable for delivery to the treatment area ofthe vasculature of a patient. Expandable implant 106 can be constrainedtoward a radially collapsed configuration and releasably mounted onto adelivery device such as catheter shaft 102. The diameter of theexpandable implant 106 in the collapsed configuration is small enoughfor the implant to be delivered through the vasculature to the treatmentarea. In various embodiments, the diameter of the collapsedconfiguration is small enough to minimize the crossing profile ofcatheter assembly 100 and reduce or prevent tissue damage to thepatient. In the collapsed configuration, the expandable implant 106 canbe guided by catheter shaft 102 through the vasculature.

In various embodiments, expandable implant 106 can comprise a radiallyexpanded configuration suitable for implanting the device in thetreatment area of a patient's vasculature. In the expandedconfiguration, the diameter of expandable implant 106 can beapproximately the same as the vessel to be repaired. In otherembodiments, the diameter of expandable implant 106 in the expandedconfiguration can be slightly larger than the vessel to be treated toprovide a traction fit within the vessel.

In various embodiments, expandable implant 106 can comprise aself-expandable device, such as a self-expandable stent graft. Suchdevices dilate from a radially collapsed configuration to a radiallyexpanded configuration when unrestrained. In other embodiments,expandable implant 106 can comprise a device that is expanded with theassistance of a secondary device such as, for example, a balloon. In yetother embodiments, catheter assembly 100 can comprise a plurality ofexpandable implants 106. The use of a catheter assembly with any numberof expandable implants is within the scope of the present disclosure.

Various medical devices in accordance with the disclosure comprise asleeve or multiple sleeves. The sleeve or sleeves may constrain anexpandable implant device in a collapsed configuration for endoluminaldelivery of the implant to a treatment portion of the vasculature of apatient. For the purposes of the disclosure, the term “constrain” maymean (i) to limit the expansion, either through self-expansion orassisted by a device, of the diameter of an expandable implant or (ii)to cover or surround but not otherwise restrain an expandable implant(e.g., for storage or biocompatibility reasons and/or to provideprotection to the expandable implant and/or the vasculature). Catheterassembly 100, for example, comprises a sleeve 104 which surrounds andconstrains expandable implant 106 toward a reduced diameter or collapsedconfiguration.

After deployment, the sleeve or sleeves can be removed in order to allowthe expandable implant to expand toward a functional diameter andachieve a desired therapeutic outcome. Alternatively, the sleeve orsleeves can remain coupled to the implant or otherwise implanted whilenot interfering with the expandable implant.

In various embodiments, an expandable implant is constrained by a singlesleeve which circumferentially surrounds the expandable implant. Forexample, with reference to FIG. 2B, catheter assembly 200 comprises asleeve 204. In various embodiments, sleeve 204 circumferentiallysurrounds expandable implant 206 and constrains it toward a collapsedconfiguration, in which the diameter is less than the diameter of anunconstrained or otherwise deployed implant. For example, sleeve 204 mayconstrain expandable implant 206 toward a collapsed configuration fordelivery within the vasculature.

In other embodiments, an expandable implant is constrained by aplurality of sleeves which circumferentially surround the expandableimplant, which allow the expandable implant to be deployed and held atintermediate configurations larger than the collapsed configuration andsmaller than the deployed configuration. The plurality of sleeves cancomprise at least two sleeves which circumferentially surround eachother.

In various embodiments, sleeves can be tubular and serve to constrain anexpandable implant. In such configurations, sleeves are formed from asheet of one or more materials wrapped or folded about the expandableimplant. While the illustrative embodiments herein are described ascomprising one or more tubular sleeves, sleeves of any non-tubular shapethat corresponds to an underlying expandable implant or that areotherwise appropriately shaped for a given application are also withinthe scope of the present disclosure.

In various embodiments, sleeves are formed by wrapping or folding thesheet of material(s) such that two parallel edges of the sheet aresubstantially aligned. Said alignment may or may not be parallel to orcoaxial with the catheter shaft of a catheter assembly. In variousembodiments, the edges of the sheet of material(s) do not contact eachother.

In various embodiments, the edges of the sheet of material(s) do contacteach other and are coupled with a coupling member (as described below)an adhesive, or the like. In various other embodiments, the edges of thesheet of material(s) are aligned so that the edges of the same side ofthe sheet or sheets (e.g., the front or back of the sheet) are incontact with each other. In still other embodiments, the edges ofopposite sides of the sheet of material(s) are in contact with eachother, such that the edges overlap each other, such that a portion ofone side of the sheet is in contact with a portion of the other side.Said another way, the front of the sheet may overlap the rear of thesheet, or vice versa.

In various embodiments, sleeves comprise materials similar to those usedto form a graft member. For example, a precursor flexible sheet used tomake the sleeve can be formed from a flattened, thin wall ePTFE tube.The thin wall tube can incorporate “rip-stops” in the form oflongitudinal high strength fibers attached or embedded into the sheet ortube wall.

The sheet of material(s) used to form the sleeve(s) can comprise aseries of openings, such that the openings extend from one edge of thesheet to the other. In such configurations, a coupling member can bewoven or stitched through the series of openings in the sheet ofmaterial(s), securing each of the two edges together and forming a tube.For example, in FIG. 1, coupling member 124 secures the edges of sleeve104 such that sleeve 104 maintains expandable implant 106 toward areduced diameter or outer peripheral dimension suitable for endoluminaldelivery.

In various embodiments, the coupling member can comprise a woven fiber.In other embodiments, the coupling member can comprise a monofilamentfiber. Any type of string, cord, thread, fiber, or wire which is capableof maintaining a sleeve in a tubular shape is within the scope of thepresent disclosure.

In various embodiments, a single coupling member can be used toconstrain the diameter of one or more sleeves. In other embodiments,multiple coupling members can be used to constrain the diameter of oneor more sleeves.

Once a suitable expandable implant is in a collapsed configuration, theexpandable implant can be deployed within the vasculature of a patient.An expandable implant in a collapsed configuration can be introduced toa vasculature and directed by a catheter assembly to a treatment area ofthe vasculature. Once in position in the treatment area of thevasculature, the expandable implant can be expanded to an expandedconfiguration.

When the expandable implant is in position within the vasculature, thecoupling member or members can be disengaged from the sleeve or sleevesfrom outside of the body of the patient, which allows the sleeve(s) toopen and the expandable implant to expand. As discussed above, theexpandable implant can be self-expanding, or the implant can be expandedby an expanding device, such as a balloon.

The coupling member or members can be disengaged from the sleeve orsleeves by a mechanical mechanism operated from outside of the body ofthe patient. For example, the member or members can be disengaged byapplying sufficient tension to the member or members. In anotherexample, a translatable element can be attached to the coupling memberor members outside of the body. Displacement of the translatableelements, such as rotation of a dial or rotational member or translationof a handle or knob, may provide sufficient tension to displace anddisengage the coupling member or members.

In various embodiments, disengaging a single coupling member whichcloses a single sleeve from the sleeve allows the expandable device tobe expanded toward a larger diameter or outer peripheral dimension. Forexample, with reference to FIG. 2A, catheter assembly 200 can be used todeliver an implant expandable implant 206 to a treatment area of avasculature. Expandable implant 206 has a collapsed diameter fordelivery, and sleeve 204 circumferentially surrounds expandable implant206 and is held closed by coupling member 224. As described in moredetail below, bending of expandable implant 206 can be controlled priorto full expansion (e.g., at an intermediate diameter) to help facilitatedelivery to the desired position. Once expandable implant 206 is inposition relative to the treatment area, coupling member 224 isdisengaged from sleeve 204 and sleeve 204 is released, allowingexpandable implant 206 to expand toward a larger diameter.

As mentioned above, in various embodiments of the present disclosure, anexpandable implant may further comprise an intermediate configuration.In the intermediate configuration, the diameter of the expandableimplant is constrained in a diameter smaller than the expandedconfiguration and larger than the collapsed configuration. For example,the diameter of the expandable device in the intermediate configurationcan be about 50% of the diameter of the expandable device in theexpanded configuration. However, any diameter of the intermediateconfiguration which is less than the diameter of the expandedconfiguration and larger than the collapsed configuration is within thescope of the invention.

In such embodiments, the expandable implant can be expanded from thecollapsed configuration toward the intermediate configuration once theimplant has been delivered near the treatment area of the vasculature ofa patient. The intermediate configuration may, among other things,assist in properly orienting and locating the expandable implant withinthe treatment area of the vasculature.

In various embodiments, an expandable implant can be concentricallysurrounded by two sleeves having different diameters. In suchconfigurations, a primary sleeve constrains the expandable implanttoward the collapsed configuration. Once the collapsed configurationsleeve is opened, a secondary sleeve constrains the expandable implanttoward the intermediate configuration. As discussed above, theexpandable implant can be self-expanding, or the implant can be expandedby a device, such as a balloon.

For example, with reference to FIG. 2A, a catheter assembly 200comprises an expandable implant 206 and sleeve 204. Secondary sleeve 204constrains expandable implant 206 toward an intermediate configuration.Secondary sleeve 204 is held in position around expandable implant 206by secondary coupling member 224.

Catheter assembly 200 further comprises a primary sleeve 208, whichconstrains expandable implant 206 toward a collapsed configuration fordelivery to the vasculature of a patient. Primary sleeve 208 is held inposition around expandable implant 206 by primary coupling member 234.

Once expandable implant 206 is sufficiently close to the treatment areaof the vasculature, primary coupling member 234 is disengaged fromprimary sleeve 208, which releases primary sleeve 208 and allowsexpanded implant 206 to expand toward a larger diameter.

With reference to FIG. 2B, after primary sleeve 208 has been expanded,secondary sleeve 204 constrains the expandable implant 206 toward theintermediate configuration. In the intermediate configuration, asmentioned above and as described in more detail below, expandableimplant 206 can be oriented and adjusted (e.g., by bending and torsionalrotation) to a desired location within the treatment area of thevasculature.

In other embodiments of the present disclosure, a single or “mono”sleeve can be used to constrain the expandable implant in both acollapsed configuration and an intermediate configuration. For example,with reference to FIGS. 3A-3D, catheter assembly 300 comprises anexpandable implant 306, a monosleeve 304, a primary coupling member 334,and a secondary coupling member 324.

Monosleeve 304 further comprises a plurality of secondary holes 332. Inthis configuration, secondary coupling member 324 is stitched or woventhrough secondary holes 332, constricting monosleeve 304 and expandableimplant 306 to the diameter of an intermediate configuration. In theintermediate configuration, the diameter of expandable implant 306 isless than the expanded diameter and larger than the diameter of thecollapsed configuration. In the intermediate configuration, as describedin more detail below, expandable implant 306 can be oriented andadjusted (e.g., by bending and torsional rotation) to a desired locationwithin the treatment area of the vasculature.

Monosleeve 304 further comprises a plurality of primary holes 330. Inthis configuration, primary coupling member 334 is stitched or woventhrough primary holes 330, constricting monosleeve 304 and expandableimplant 306 toward the collapsed configuration. The diameter or outerperipheral dimension of the collapsed configuration is selected to allowfor endoluminal delivery of the expandable implant 306 to the treatmentarea of the vasculature of a patient.

Once expandable implant 306 has been delivered to a region near thetreatment area of the vasculature, primary coupling member 334 can bedisengaged from monosleeve 304, allowing expandable implant 306 to beexpanded toward the intermediate configuration. Expandable implant 306can be oriented and adjusted (e.g., by bending and torsionally rotating)to a desired location within the treatment area of the vasculature.After final positioning, secondary coupling member 324 can be disengagedfrom monosleeve 304, and expandable implant 306 can be expanded towardthe expanded configuration.

Although a number of specific configurations of constraining members(for example, primary and secondary members) and sleeves (for example,primary and secondary sleeves) have been discussed, the use of anynumber and/or configuration of constraining members and any number ofsleeves is within the scope of the present disclosure. Further, theexpandable implant may be allowed to partially expand toward theintermediate and expanded configurations by partially selectivelydisengaging the secondary and primary coupling members from themonosleeve, respectively.

In various embodiments, the catheter assembly further comprises asteering line. In such configurations, tension can be applied to thesteering line to displace the steering line and bend the expandableimplant. Bending the expandable implant may, among other things, assistin travelling through curved or tortuous regions of vasculature. Bendingthe expandable implant may also allow the implant to conform tocurvatures in the vasculature of a patient.

For example, with reference to FIGS. 2A-2B, steering line 220 passesfrom the outside of the body of a patient, through catheter shaft 202,and is releasably coupled to expandable implant 206. In suchconfigurations, steering line 220 can be threaded through expandableimplant 206 such that tension applied to steering line 220 from outsideof the body of the patient causes expandable implant 206 to bend in adesired manner.

As a further example, with reference to FIG. 6, an expandable implant606 is illustrated. Steering line 620 is threaded along the surface ofexpandable implant 606.

In various embodiments, steering line 220 can comprise metallic,polymeric or natural materials and can comprise conventional medicalgrade materials such as nylon, polyacrylamide, polycarbonate,polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, elastomeric organosilicon polymers; metals such asstainless steels, cobalt-chromium alloys and nitinol. Elongated membersor lock wires can also be formed from high strength polymer fibers suchas ultra high molecular weight polyethylene fibers (e.g., Spectra®,Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.).

With reference to FIGS. 7A-H, cross-sectional views of variousexpandable implant configurations are illustrated. In variousembodiments, an expandable implant can comprise a stent 705 and a graftmember 707, which are surrounded by sleeve 704. In such configurations,a steering line 720 can be threaded through stent 705, graft member 707,and/or sleeve 704 in a variety of different patterns. Such patterns may,among other benefits, facilitate the bending of the expandable implantby applying tension to (and corresponding displacement of) steering line720 from outside of the body. Further, such patterns may reduce orprevent steering line 720 from damaging tissue within the vasculature ofthe patient by limiting or preventing “bowstringing.” Bowstringingoccurs when a string or thread travels in a direct line between twopoints on the inside of a curve in an expandable graft. This may causethe string or thread to come into contact with and potentially damagetissue in the vasculature. Bowstringing and its effects on tissue mayalso be reduced and/or minimized by sleeve 704 as sleeve 704 surroundssteering line 720 during bending and prior to full expansion of theexpandable implant.

As illustrated in FIGS. 7B-7H, steering line 720 can be woven throughany combination of stent 705, graft member 707, and sleeve 704. In eachfigure described below, a segment of a pattern is described. A steeringline can be woven between a stent, graft member, and sleeve in anycombination of these patterns. Alternatively, the steering line mayinteract with an expandable implant and one or more sleeves in anymanner which allows steering line 720 to bend the expandable implant ina desired manner.

In FIG. 7B, steering line 720 is threaded between the inner wall ofsleeve 704 and stent 705. In FIG. 7C, steering line 720 passes between afirst apex 751 of stent 705 and the outer wall of graft member 707,passes between second apex 742 and the inner wall of sleeve 704, extendsinto and through the wall of graft member 707, reenters graft member707, passes between a third apex 753 of stent 705 and the inner wall ofsleeve 704, and passes between a fourth apex 754 and the inner wall ofsleeve 704. In FIG. 7D, steering line 720 passes between first apex 751and the outer wall of graft member 707, then between second apex 752 andthe inner wall of sleeve 704.

In FIG. 7E, steering line 720 passes between first apex 751 and theouter wall of graft member 707, extends through the outer wall of graftmember 707, reenters graft member 707, and passes between third apex 753and the outer wall of graft member 707 In FIG. 7F, steering line 720passes between the outside wall of graft member 707 and stent 705.

In FIG. 7G, steering line 720 passes from the inner wall of graft member707, through to the outer wall of graft member 707 between first apex751 and second apex 752, back through to the outer wall of graft member707, and back through to the inner wall of graft member 707 betweenthird apex 753 and fourth apex 754. In FIG. 7H, steering line 720 isdisposed against the inner wall of graft member 707. As discussedpreviously, FIGS. 7B-7G illustrate example patterns in which a steeringline may interact with an expandable implant. Any way in which asteering line interacts with an expandable implant to facilitate bendingof the implant is within the scope of the present disclosure.

In various embodiments, a catheter assembly can comprise more than onesteering line. For example, with reference to FIG. 9, catheter assembly900 comprises two steering lines 920. As described in relation to FIGS.7A-7G, steering lines 920 can be woven through the surface of expandableimplant 906. In various embodiments, steering lines 920 may exitcatheter shaft 902 and engage expandable implant 906 near the proximalend of expandable implant 906. In such configurations, steering lines920 may travel across and remain substantially in contact with thesurface of expandable implant 906 from the proximal end to the distalend. Steering line 920 may then disengage the surface of expandableimplant 906 and become secured to catheter assembly 900.

In various embodiments, steering lines 920 traverse and interact withthe surface of expandable implant 906 in a pattern which facilitatescontrollable bending of expandable implant 906. For example, asillustrated in FIG. 9, steering lines 920 may traverse the surface ofexpandable implant 906 such that, across a significant portion ofexpandable implant 906, both steering lines 920 are parallel to and inclose proximity with each other. Such a configuration allows the tensionapplied to steering lines 920 to work together to form a bend orcurvature in the same segment of expandable implant 906. Anyconfiguration of steering lines 920 and surface of expandable implant906 which allows for selective and controllable bending of expandableimplant 906 is within the scope of the present disclosure.

In various embodiments, one or more steering lines are configured toenable selective and controllable bending of an expandable implant, forexample as described above, and also to enable non-concentric, temporaryengagement of an expandable implant in relation to a catheter assembly.For example, it can be desirable for a portion of the inner surface ofan expandable implant to be temporarily engaged distal to a catheterassembly. Such a portion, for example, can be that which will exhibitthe longest radius of curvature during selective and controllablebending of the expandable implant, whether during and/or after itsdelivery and deployment. Such a portion can thus be an outer curveportion of an expandable implant.

To accomplish the aforesaid objectives, in various embodiments, one ormore steering lines can begin and terminate at distal and proximal endsrespectively along an edge of an expandable implant which will exhibitthe longest radius of curvature during selective and controllablebending. Between the distal and proximal ends, the one or more steeringlines can transition toward and along an edge of an expandable implantwhich will exhibit the shortest radius of curvature during selective andcontrollable bending.

For example, with reference to FIG. 10A, a catheter assembly 1000 isillustrated as having a catheter shaft 1002 temporarily engaged distalto an outer curve portion of the inner surface of an expandable implant1006 by two steering lines 1020, each comprising a helical pattern. Asdescribed in relation to FIGS. 7A-7G, steering lines 1020 can be woventhrough the surface of expandable implant 1006. In various embodiments,steering lines 1020 may exit catheter shaft 1002 and engage expandableimplant 1006 near the distal end of expandable implant 1006. In suchconfigurations, steering lines 1020 may travel across and remainsubstantially in contact with the surface of expandable implant 1006from the distal end to the proximal end. Steering line 1020 may thendisengage the surface of expandable implant 1006 and become secured tocatheter assembly 1000.

As illustrated in FIGS. 10B-10D, which illustrate inner curve, outercurve, and open views respectively of the expandable implant andsteering lines illustrated in FIG. 10A, the helical pattern of eachsteering line 1020 begins near the distal end on the outer curve ofexpandable implant 1006 and terminates proximal thereto on the innercurve of expandable implant 1006. Each steering line 1020 continues in adirection substantially parallel to the central axis of expandableimplant 1006 toward the proximal end on the inner curve of expandableimplant 1006, where it circumferentially traverses expandable implant1006 back to its outer curve. As illustrated in FIGS. 10B-10D, thepattern of each steering line 1020 mirrors the other across a sagittalplane through the central axis of expandable implant 1006. In thismanner, steering lines 1020 cooperate to enable selective andcontrollable bending of expandable implant 1006, and also to enablenon-concentric, temporary engagement of expandable implant 1006 inrelation to catheter shaft 1002. Any configuration of steering lines1020 and surface of expandable implant 1006 which allows for selectiveand controllable bending and non-concentric, temporary engagement ofexpandable implant 1006 is within the scope of the present disclosure.

For example, and as illustrated in FIG. 11A, the helical pattern of thesteering line 1120 begins on the exterior of expandable implant 1106near the distal end on the outer curve of expandable implant 1106 andterminates proximal thereto on the inner curve of expandable implant1106. The steering line 1120 continues on the inner curve in a directionsubstantially parallel to the central axis of expandable implant 1106and toward the proximal end on the inner curve of expandable implant1106. From the proximal end, the steering line 1120 enters expandableimplant 1106 and returns to the distal end at the outer curve ofexpandable implant 1106, where it is locked with a distal pin. FIG. 11Billustrates a similar configuration, where like tensile forces F areapplied to the steering line 1120, but where the steering line 1120 isthreaded and locked in an opposite configuration.

In various embodiments, steering lines may traverse a path across and/orthrough the surface of expandable implant that is at least partiallyparallel to and substantially covered by one or more sleeves.

In various embodiments, the catheter assembly may further comprise alock wire. In such embodiments, the lock wire may secure a steering lineor lines to the catheter assembly. For example, with reference to FIG.8, catheter assembly 800 comprises a catheter shaft 802, expandableimplant 806, two steering lines 820, and a lock wire 880. Lock wire 880passes from outside of the body of the patient, through catheter shaft802, and exits at a point near catheter tip 818. At this point, itinteracts with steering lines 820, then reenters catheter shaft 802 andcontinues to catheter tip 818. In such a configuration, lock wire 880releasably couples steering lines 820 to catheter assembly 800. Anymanner in which lock wire 880 may interact with steering line or lines820 to maintain a releasable coupling between steering line or lines 820and catheter assembly 800 is within the scope of the present disclosure.

In various embodiments, each steering line may further comprise an endloop. For example, with reference to FIG. 9, each steering line 920comprises an end loop 922. Lock wire 980 may pass through each end loop922, securing each steering line 920 to catheter assembly 900. Anymethod of securing steering line or lines 920 to catheter assembly 900is within the scope of the invention.

In various embodiments, lock wires can be formed from metallic,polymeric or natural materials and can comprise conventional medicalgrade materials such as nylon, polyacrylamide, polycarbonate,polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, elastomeric organosilicon polymers; metals such asstainless steels, cobalt-chromium alloys and nitinol. Elongated membersor lock wires can also be formed from high strength polymer fibers suchas ultra high molecular weight polyethylene fibers (e.g., Spectra®,Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.).

In various embodiments, a catheter assembly used to deliver anexpandable implant comprises a catheter shaft, an expandable implant,one or more sleeves, one or more steering lines, and a lock wire. Insuch configurations, the expandable implant is capable of bending,through tension applied to the one or more steering lines andcorresponding displacement, to conform to curvature in the vasculatureof a patient.

For example, with reference to FIGS. 5A-D, a catheter assembly 500comprising an expandable implant 506 is illustrated. Catheter assembly500 further comprises two steering lines 520, a lock wire 580, a primarycoupling member 524, and a secondary coupling member 534. Primarycoupling member 524 is releasably coupled to primary sleeve 504.Secondary coupling member 534 is releasably coupled to secondary sleeve508.

Catheter assembly 500 is inserted into the vasculature of a patient, andexpandable implant 506 is advanced to a treatment area of thevasculature. Upon arriving at a location close to the treatment area,primary coupling member 524 can be disengaged from primary sleeve 504,allowing expandable implant 506 to be expanded to an intermediateconfiguration. In various embodiments, sleeve 504 can be removed fromthe vasculature once primary coupling member 524 has been disengaged.

With reference to FIG. 5B, upon expansion to an intermediateconfiguration, tension can be applied to steering lines 520, causingexpandable implant 506 to bend in a desired manner. For example,expandable implant 506 can bend in a direction aligned with the locationof steering lines 520. Once expandable implant 506 has been sufficientlybent, consistent tension is applied to steering lines 520 to maintainthe degree of bending.

In various embodiments, tension can be applied to steering lines 520 bypulling the lines from the outside of the body of the patient. In otherembodiments, steering lines 520 can be connected to one or more dials orother mechanisms for applying the tension at the trailing end ofcatheter shaft 502. In this configuration, the dial can be used to applya desired tension, as well as maintain the correct amount of tensiononce a desired angle of bending of expandable implant 506 has beenachieved. Various embodiments may also comprise an indicator, scale,gradient, or the like which demonstrates the amount of tension ordisplacement of the steering line, and/or the amount of bending inexpandable implant 506. In various embodiments, the catheter assemblycan comprise one more additional markings (e.g., on a handle) that allowa user to determine the orientation of the steering line with respect tothe vasculature.

After a sufficient degree of bending has been achieved in expandableimplant 506, the implant can be rotated for final positioning in thetreatment area of the vasculature. In various exemplary embodiments,lock wire 580 is engaged with steering lines 520 such that torsionalrotation of the catheter shaft causes expandable implant 506 to rotatewithin the vasculature. However, any configuration of catheter assembly500 which allows for rotation of expandable implant 506 is within thescope of the present disclosure.

In various embodiments, an expandable implant may further comprise oneor more radiopaque markers. In one embodiment, one or more radiopaquemarkers form a band around the distal end of the expandable implant. Insuch configurations, the radiopaque markers may assist in deployment ofan expandable implant by providing increased visibility when observingthe expandable implant with a radiographic device, such as an x-raymachine. Any arrangement of radiopaque markers which assists indeployment of an expandable implant is within the scope of the presentdisclosure.

In various embodiments, radiopaque markers may assist in orienting theexpandable implant by providing a profile view of the distal end of theexpandable implant. For example, with reference to FIG. 4, a number ofpotential profiles 491-495 of the distal end of an expandable implant406 are illustrated. In such configurations, radiopaque markers locatedin the distal end of expandable implant 406 provide a profile view ofthe distal end of expandable implant 406 when viewed by a radiographicdevice. Such profile views can be used to properly orient expandableimplant 406 by assisting a user in determining the degree of rotationand/or orientation of a bend in expandable implant 406.

For example, profile 491 represents a distal end of an expandableimplant 406 having an orientation substantially orthogonal to aradiographic image capture device, such as an x-ray camera. Profile 492represents a distal end of an expandable implant having an orientationless orthogonal than profile 491. Profile 493 represents a distal end ofan expandable implant 406 having an orientation less orthogonal thanprofile 492. Finally, profile 494 represents a distal end of anexpandable implant 406 having an orientation parallel to a radiographicimage capture device.

After expandable implant 506 has been properly oriented and locatedwithin the treatment area of the patient, secondary coupling member 534can be disengaged from secondary sleeve 508. Once secondary couplingmember 534 is disengaged from secondary sleeve 508, expandable implant506 can be expanded to a final position and diameter within thetreatment area. In various exemplary embodiments, secondary sleeve 508is removed from the vasculature. In other exemplary embodiments,secondary sleeve 508 remains in position circumferentially surrounding aportion of expandable implant 506.

With reference to FIG. 5C, after expandable implant 506 is in positionand expanded within the vasculature, lock wire 580 can be disengagedfrom catheter assembly 500. In various embodiments, lock wire 580 isdisengaged by applying sufficient tension to the lock wire 580 fromoutside of the body of the patient. After lock wire 580 is disengaged,steering lines 520 can be released from coupling with catheter shaft 502and can be removed from expandable implant 506 and catheter assembly500.

As illustrated in FIG. 5D, after primary and secondary coupling members524 and 534, steering lines 520, and lock wire 580 are removed fromcatheter assembly 500, catheter assembly 500 is fully disengaged fromexpandable implant 506, and can be removed from the vasculature of thepatient.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present disclosurewithout departing from the spirit or scope of the disclosure. Thus, itis intended that the present disclosure cover the modifications andvariations of this disclosure provided they come within the scope of theappended claims and their equivalents.

Likewise, numerous characteristics and advantages have been set forth inthe preceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications can be made, especially in matters of structure,materials, elements, components, shape, size and arrangement of partsincluding combinations within the principles of the disclosure, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

What is claimed is:
 1. A catheter assembly comprising: a catheter havinga leading end and a trailing end and comprising a main lumen extendingbetween the leading end and the trailing end; an expandable tubulardevice positioned at the leading end of the catheter, the expandabletubular device having a proximal end and a distal end and a collapsedconfiguration for endoluminal delivery of the expandable tubular deviceto a treatment site and an expanded configuration having a diameterlarger than the diameter of the collapsed configuration; a primarysleeve wrapped circumferentially around the expandable tubular device,wherein the primary sleeve comprises a sheet of material having firstand second major surfaces and a plurality of openings extending from thefirst major surface to the second major surface; and a primary elongatecoupling member cooperating with the openings for releasably couplingportions of the sheet to one another to constrain the expandable tubulardevice toward the collapsed configuration; and at least one steeringline extending through the main lumen of the catheter and at leastdisposed between the expandable tubular device and the primary sleeve toallow selective bending of the expandable tubular device andnon-concentric engagement of the expandable tubular device in relationto the catheter, the at least one steering line helically transitioningalong the length of the expandable tubular device through the distal endand through the proximal end of the expandable tubular device atdiametrically opposing surfaces thereof.
 2. The catheter assembly ofclaim 1, wherein the at least one steering line begins at a distal endof the expandable tubular device on an outer curve of the expandabletubular device, wherein the at least one steering line terminates at aproximal end of the expandable tubular device on an inner curve of theexpandable device.
 3. The catheter assembly of claim 2, wherein the atleast one steering line comprises a first steering line and a secondsteering line.
 4. The catheter assembly of claim 3, wherein the firststeering line mirrors the second steering line across a sagittal planethrough an axis of the expandable tubular device.
 5. The catheterassembly of claim 1, wherein the at least one steering line begins on anexterior at the distal end of the expandable tubular device on an outercurve of the expandable tubular device, wherein the at least onesteering line helically transitions between the distal end and theproximal end toward an inner curve of the expandable tubular device,wherein the at least one steering line enters into an interior of theexpandable tubular device at a proximal end of the expandable tubulardevice on the inner curve of the expandable tubular device, wherein theat least one steering line returns from the proximal end of theexpandable tubular device toward the distal end of the expandabletubular device, and wherein the at least one steering line is secured atthe distal end of the expandable tubular device with a distal pin. 6.The catheter assembly of claim 2, further comprising a secondary sleeveand secondary elongate coupling member, wherein the secondary sleevelimits the expansion of the expandable tubular device to an intermediateconfiguration having a diameter larger than the diameter of thecollapsed configuration and smaller than the diameter of the expandedconfiguration.
 7. The catheter assembly of claim 2, wherein theexpandable tubular device comprises a stent graft.
 8. The catheterassembly of claim 7, wherein the stent graft comprises at least oneapex, and wherein the at least one steering line is woven through the atleast one apex of the stent graft.
 9. The catheter assembly of claim 2,wherein the at least one steering line is removable.
 10. The catheterassembly of claim 2, wherein the expandable tubular device is releasablycoupled to the catheter.
 11. The catheter assembly of claim 10, furthercomprising a lock wire extending through the main lumen, wherein thelock wire releasably engages the at least one steering line.
 12. Thecatheter assembly of claim 6, wherein the at least one steering line isdisposed within the secondary sleeve such that when the catheterassembly is inserted into a vessel, the at least one steering lineremains covered by the secondary sleeve.
 13. The catheter assembly ofclaim 6, wherein the at least one steering line is disposed within thesecondary sleeve such that when the catheter assembly is inserted into avessel, the at least one steering line does not directly contact tissuewithin the vessel.
 14. The catheter assembly of claim 2, wherein theexpandable tubular device is bendable more than about 90 degreesrelative to an axis of the catheter.
 15. The catheter assembly of claim2, wherein the degree of bending of the expandable tubular devicerelative to an axis of the catheter is proportional to the amount oftension on the at least one steering line.
 16. The catheter assembly ofclaim 2, wherein the degree of bending of the expandable tubular devicerelative to an axis of the catheter is proportional to the amount ofdisplacement of the at least one steering line.
 17. The catheterassembly of claim 2, wherein the expandable tubular device substantiallymaintains a desired bending radius while the expandable tubular deviceis deployed to an expanded configuration.
 18. The catheter assembly ofclaim 2, wherein the at least one steering line is connected to theproximal end of the expandable tubular device.
 19. The catheter assemblyof claim 2, further comprising a radiopaque marker located at a proximalend of the expandable tubular device.
 20. The catheter assembly of claim19, wherein the radiopaque marker comprises a band extending around aperimeter of the expandable tubular device.
 21. The catheter assembly ofclaim 19, wherein the catheter assembly is viewed with a radiographicdevice located outside of a patient's body, and wherein when theexpandable tubular device is properly positioned within the treatmentsite, a two dimensional profile of the radiopaque marker issubstantially a line.
 22. The catheter assembly of claim 2, wherein theat least one steering line torsionally anchors the expandable tubulardevice and catheter allowing rotational positioning of device attreatment site via rotation of catheter.
 23. The catheter assembly ofclaim 6, further comprising a first and second secondary elongatecoupling member, wherein the first secondary elongate coupling member isthreaded along approximately half of the length of the secondary sleeveand the second secondary elongate coupling member is threaded along theother approximately half of the secondary sleeve.
 24. The catheterassembly of claim 2, further comprising a secondary elongate couplingmember and a plurality of secondary openings, wherein the secondaryelongate coupling member cooperates with the secondary openings forreleasably coupling portions of the sheet to one another to constrainthe expandable tubular device in an intermediate configuration, theintermediate configuration having a diameter larger than the collapsedconfiguration and smaller than the expanded configuration.
 25. Acatheter assembly comprising: a catheter having a leading end and atrailing end and comprising a main lumen extending between the leadingend and the trailing end; an expandable tubular device positioned at theleading end of the catheter, the expandable tubular device having aproximal end and a distal end and a collapsed configuration forendoluminal delivery of the expandable device to a treatment site and anexpanded configuration having a diameter larger than the diameter of thecollapsed configuration; a primary sleeve wrapped circumferentiallyaround the expandable tubular device, wherein the primary sleevecomprises a sheet of material having first and second major surfaces anda plurality of openings extending from the first major surface to thesecond major surface; and a primary elongate coupling member cooperatingwith the openings for releasably coupling portions of the sheet to oneanother to constrain the expandable tubular device toward the collapsedconfiguration; and at least one steering line extending through the mainlumen of the catheter and extending generally helically about theexpandable tubular device between the expandable device and the primarysleeve to allow bending of the expandable device in response toselective tensioning of the at least one steering line, the at least onesteering line helically transitioning along the length of the expandabledevice through the distal end and through the proximal end of theexpandable tubular device at diametrically opposing surfaces thereof.